Validation Engineer jobs in Newark, DE
Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Recently Added Validation Engineer jobs
Cleaning Validation Specialist
- Quotient Sciences
-
Boothwyn, PA
FULL_TIME
-
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it.
People join Quotient Sciences because we are a respected member of the drug development community that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
The Role- The Cleaning Validation Specialist is responsible for coordinating the cleaning validation activities , including but not limited to preparing and executing the protocols and reports for cleaning validation.
- This position will lead all efforts for cleaning method development and will work closely with Analytical Development team for executing the cleanability studies.
- This position will maintain the “Cleaning validation matrix” and will work with cross functional teams for introduction and assessment of new project.
- Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation.
- Perform investigation of deviations / discrepancies. Oversees and reviews validation area processes.
- Design and develop cleaning procedures for new products and manufacturing equipment.
- Provide technical support to cleaning activities associated with the manufacturing process.
- Lead the cleaning validation program and activities to keep up with manufacturing requirements and control cleaning related failures.
- Use of cleaning agents and the establishment of sound cleaning practices within new or refurbished manufacturing rooms and cleaning/sampling suites areas.
- Designs and supports the implementation, i.e. provides training, of cleaning strategies for product transfer projects and product development projects.
- Investigates and conducts troubleshooting and root cause analysis of cleaning related incidents, deviations and CAPA. Complete Action items as assigned.
- Create, and review manufacturing cleaning Working Instructions, Standard Operating Procedures, Batch Records, Study Protocols and Cleaning Validation documentations.
- Supports the periodic review of cleaning validation studies.
- Issues Change Controls required for the implementation of cleaning procedure changes, as needed.
- Trains manufacturing and QC/QA personnel on cleaning validation documentation.
- Perform cleanability studies and visible limit studies to determine the appropriate detergent and cleaning limits for new product development.
- Conduct data analysis in Minitab to draw conclusions for various cleaning studies.
- Conduct cleaning risk assessment on manufacturing equipment to determine difficult-to-clean surfaces and potential swab locations.
- Masters degree in a scientific field or an equivalent combination of education and experience.
- Minimum three (3) years of experience in Production or validation related field
- Competent in the use of Microsoft Office packages including Word, Excel, PowerPoint, Outlook.
- Experience and knowledge of within GMP regulated environment/department
- Experience and knowledge of statistical software like Minitab.
- Preferable experience of working in a Solid oral dose manufacturing environment or equivalent experience in another role.
When applying for a position with Quotient Sciences you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient family and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. - 26 Days Ago
Computer System Validation Specialist
- Frontage Laboratories
-
Exton, PA
TEMPORARY
- Computer System Validation Specialist TemporaryEagleview PA Frontage Laboratories Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product developm...
- 1 Month Ago
SVP, Fraud Model Validation Sr. Lead
- Citi
-
WILMINGTON, DE
OTHER
- The Specialized Analytics Sr Lead is a strategic professional who closely follows latest trends in own field and adapts them for application within own job and the business. Typically a small number o...
- 22 Days Ago
Director, Computer System Validation and Application Support
- Frontage Laboratories
-
Exton, PA
FULL_TIME
- Director, Computer System Validation and Application SupportTitle: Director, Computer System Validation and Application SupportLocation: Exton, PAReports to: VP, QA and IT compliance Full-time (40 hrs...
- 12 Days Ago
Engineer III
- State of Delaware
-
Dover, DE
OTHER
- IntroductionMake a Difference with DHSS Our mission at the Department of Health and Social Services (DHSS) is to improve the quality of life of Delaware citizens by promoting health and well-being, fo...
- 18 Days Ago
Field Engineer
- Tri-M Group
-
Kennett, PA
FULL_TIME
- Here at The Tri-M Group, LLC we are an employee owned company placing our employees first, knowing that highly trained, skilled and compensated workforce can better serve our customers, families and o...
- 18 Days Ago
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0 Validation Engineer jobs found in Newark, DE area
Software Quality Engineer
- CGI Group, Inc.
-
Plymouth Meeting, PA
- Software Quality Engineer Position Description CGI is seeking a seasoned MES software quality engineer to join our growi...
- 4/28/2024 12:00:00 AM
POSITION TITLE: Sr. IT Engineering Specialist
- Ecclesiastes Inc
-
Newark, DE
- Job Description Job Description POSITION DUTIES:Develop Automation framework to automate the functionality of business-c...
- 4/28/2024 12:00:00 AM
Field Service Engineer (Wilmington, DE) - remote
- SCIEX
-
Wilmington, DE
- For over 50 years, SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillar...
- 4/28/2024 12:00:00 AM
Field Service Engineer (Wilmington, DE) - remote
- Sciex
-
Wilmington, DE
- For over 50 years, SCIEX has been developing groundbreaking technologies and solutions in mass spectrometry and capillar...
- 4/28/2024 12:00:00 AM
Software Quality Engineer
- CGI Technologies and Solutions, Inc.
-
Plymouth Meeting, PA
- **Software Quality Engineer** **Category:** Software Development/ Engineering **Main location:** United States, Pennsylv...
- 4/27/2024 12:00:00 AM
Fleet Services Engineer entry level (remote)
- NAES
-
New Castle, DE
- Opportunity Summary The Fleet Services Engineer assists in the safe and efficient operation of the power plant and the s...
- 4/27/2024 12:00:00 AM
Engineering Manager- Multi-Site
- LaMotte Company
-
Newark, DE
- Position Summary: LaMotte is searching for a Multi-Site Engineering Manager for the Newark, DE and Chestertown, MD facil...
- 4/24/2024 12:00:00 AM
SQE Validation Lead (LabX)
- CGI Group, Inc.
-
Plymouth Meeting, PA
- SQE Validation Lead (LabX) Position Description CGI is seeking a seasoned validation software quality lead join our grow...
- 4/24/2024 12:00:00 AM
About Newark, Delaware
Newark (/ˈnuːɑːrk/ NEW-ark)[note 1] is a city in New Castle County, Delaware, United States. It is located 12 miles (19 km) west-southwest of Wilmington. According to the 2010 Census, the population of the city is 31,454. Newark is home to the University of Delaware.
Newark is located at 39°41′01″N 75°44′59″W / 39.68361°N 75.74972°W / 39.68361; -75.74972 (39.6837226, −75.7496572). It is located directly east of the Maryland state line, adjacent to the unincorporated community of Fair Hill, and is less than a mile south of the tripoint where Delaware, Maryland, and Pennsylvania meet, known a...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$58,218 to $77,767
Newark, Delaware area prices
were up 1.0% from a year ago
were up 1.0% from a year ago
What does a Validation Engineer do?
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